FDA.reportPublic FDA data

LORATADINE

Product NDC
59556-917
11-digit product format
595560917
Labeler code
59556
Product ID
59556-917_0df1189a-9973-e8b7-e063-6294a90a61a3
Type
HUMAN OTC DRUG
Nonproprietary name
LORATADINE
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Strides Pharma Inc
Application
ANDA213294
Marketing category
ANDA
Marketing start
2021-08-10
Substance
LORATADINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LORATADINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LORATADINE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7AJO3BO7QN
Rxcui311373

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59556-917-01LORATADINE10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING108
59556-917-01LORATADINE1 in 1 CARTONTABLET, ORALLY DISINTEGRATING18
59556-917-02LORATADINE20 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING208
59556-917-02LORATADINE2 in 1 CARTONTABLET, ORALLY DISINTEGRATING28
59556-917-03LORATADINE30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING308
59556-917-03LORATADINE3 in 1 CARTONTABLET, ORALLY DISINTEGRATING38
59556-917-04LORATADINE40 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING408
59556-917-04LORATADINE4 in 1 CARTONTABLET, ORALLY DISINTEGRATING48
59556-917-05LORATADINE5 in 1 CARTONTABLET, ORALLY DISINTEGRATING58
59556-917-05LORATADINE50 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING508
59556-917-06LORATADINE60 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING608
59556-917-06LORATADINE6 in 1 CARTONTABLET, ORALLY DISINTEGRATING68

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59556-917LORATADINE TABLET, ORALLY DISINTEGRATING [STRIDES PHARMA INC]8Current NDC, Legacy NDC, 12 package rows20240102_16ab6610-ac99-4714-848d-9377c6bca459.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311373loratadine 10 MG 24HR Disintegrating Oral TabletPSN16ab6610-ac99-4714-848d-9377c6bca4598
311373loratadine 10 MG Disintegrating Oral TabletSCD16ab6610-ac99-4714-848d-9377c6bca4598

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59556-917-01595560917011 BLISTER PACK in 1 CARTON (59556-917-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2021-08-100000-00-00NoNoCurrent
59556-917-02595560917022 BLISTER PACK in 1 CARTON (59556-917-02) / 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2021-08-100000-00-00NoNoCurrent
59556-917-03595560917033 BLISTER PACK in 1 CARTON (59556-917-03) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2021-08-100000-00-00NoNoCurrent
59556-917-04595560917044 BLISTER PACK in 1 CARTON (59556-917-04) / 40 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 blister pack2021-08-100000-00-00NoNoCurrent
59556-917-05595560917055 BLISTER PACK in 1 CARTON (59556-917-05) / 50 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK5 blister pack2021-08-100000-00-00NoNoCurrent
59556-917-06595560917066 BLISTER PACK in 1 CARTON (59556-917-06) / 60 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK6 blister pack2021-08-100000-00-00NoNoCurrent